Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-26 @ 2:43 PM
Ignite Modification Date: 2025-12-26 @ 2:43 PM
NCT ID: NCT00853606
Description: \# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who received at least one dose of avanafil during TA-314 and who have any safety data.
Frequency Threshold: 2
Time Frame: AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
Study: NCT00853606
Study Brief: Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Avanafil All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity. None None 11 712 87 712 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
cervical spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.1) View
subdural hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (11.1) View
pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
femoral artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.1) View
inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
syncope vasovagal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.1) View
coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.1) View
atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.1) View
aortic valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.1) View
pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.1) View
small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
cervical vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (11.1) View
cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.1) View
Acute physchosis SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (11.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.1) View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.1) View
flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.1) View
nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.1) View